Hutchmed (China) Limited Stock Price, News & Analysis

Takeda Pharmaceutical has secured an exclusive licensing agreement with HUTCHMED for the development and commercialization of fruquintinib outside China, Hong Kong, and Macau. Fruquintinib, an inhibitor targeting VEGFR-1, 2, and 3, is aimed at treating refractory metastatic colorectal cancer (CRC). Takeda will pay HUTCHMED $400 million upfront, with potential additional payments of up to $730 million based on regulatory and sales milestones. The drug has shown promise in clinical trials and received Fast Track designation from the FDA. This partnership aims to enhance Takeda's oncology portfolio and expand treatment options for CRC patients.

HUTCHMED has entered an exclusive license agreement with Takeda Pharmaceutical for the global development and commercialization of fruquintinib outside China, receiving up to US$1.13 billion, including US$400 million upfront. The deal aligns with HUTCHMED's strategy to enhance profitability and broaden its market reach. Fruquintinib, already approved in China, shows promise in treating refractory metastatic colorectal cancer (CRC), as demonstrated by successful Phase III trial results. Marketing submissions in the U.S., Europe, and Japan are expected in 2023. This partnership is anticipated to accelerate HUTCHMED's growth and extend its cash runway.

HUTCHMED announced that its drug ORPATHYS (savolitinib) has been included in the National Reimbursement Drug List (NRDL) in China, effective March 1, 2023. This inclusion allows access for patients with non-small cell lung cancer (NSCLC) who have MET exon 14-skipping alterations and have not responded to platinum-based chemotherapy. ORPATHYS is the first selective MET inhibitor approved for this indication. The NRDL update has added a total of 23 oncology drugs, reflecting the government's focus on improving drug affordability. The collaboration between HUTCHMED and AstraZeneca continues to enhance treatment options for patients in need.

HUTCHMED (HCM) has completed patient enrollment for the pivotal Phase III clinical trial ESLIM-01, evaluating sovleplenib in adults with primary immune thrombocytopenia (ITP) in China. The trial, initiated in October 2021, enrolled 188 patients, with the last participant added on December 31, 2022. Topline results are expected in the second half of 2023, potentially leading to regulatory submission for marketing authorization in China. Sovleplenib is a selective oral Syk inhibitor, targeting immune disorders and certain cancers.

HUTCHMED has initiated a rolling submission of a New Drug Application (NDA) for fruquintinib, an oral VEGFR inhibitor for refractory metastatic colorectal cancer, to the U.S. FDA. The NDA, supported by the Phase III FRESCO-2 study, demonstrates a 34% reduction in the risk of death for treated patients. The company aims to complete submissions by mid-2023, with plans for European and Japanese filings. Fruquintinib is already approved in China, showcasing positive clinical outcomes in survival and progression-free metrics.

HUTCHMED (Nasdaq/AIM:HCM) has announced a strategic update aimed at accelerating profitability amid challenging market conditions in the biopharmaceutical sector. The company will prioritize its late-stage assets, particularly focusing on the global registration of fruquintinib. Selected early-stage studies will be deprioritized, with some considered for out-licensing. HUTCHMED is also exploring partnerships to commercialize its products outside China. Dr. Michael Shi will now oversee global clinical development, shifting leadership as part of this strategy.

HUTCHMED announces positive initial results from the Phase III FRUTIGA study for fruquintinib combined with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study met the primary endpoint of statistically significant improvement in progression-free survival (PFS), although overall survival (OS) was not statistically significant. The drug demonstrated a favorable safety profile consistent with prior studies. Full results are pending detailed analysis and will be shared with the NMPA for potential NDA filing.

HUTCHMED has launched a Phase II/III trial for fruquintinib combined with sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with the first patient dosed on October 27, 2022. This randomized, open-label study aims to assess the efficacy and safety of the combination against monotherapy options, with approximately 260 patients expected to enroll. The trial targets progression-free survival as the primary endpoint, addressing an unmet medical need in RCC treatment within China.

HUTCHMED has initiated a Phase II/III trial of sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA) in China, with the first patient dosed on September 30, 2022. This randomized, double-blind, placebo-controlled trial aims to evaluate the drug's safety and efficacy, enrolling approximately 110 patients. Positive Phase II results could lead to a Phase III study. Sovleplenib targets spleen tyrosine kinase (Syk), potentially effective in treating wAIHA and other B-cell disorders. HUTCHMED retains worldwide rights to this investigational drug.